Judgment_paragraph 4 · Massachusetts Institute of Technology (C-431/04)

4Article 3 of Regulation No 1768/92, which sets out the conditions for obtaining an SPC, provides:‘A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:(a) the product is protected by a basic patent in force;(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate ...;(c) the product has not already been the subject of a certificate;(d) the authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal product.’